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Kinase Inhibitor

ICP-192 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Beijing InnoCare Pharma Tech Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years old
ECOG performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug, ICP-192, on patients with advanced solid tumors and FGFR gene alterations. The trial has two parts, with the first part testing different doses of the drug to see what is safe and effective, and the second part expanding the study to more patients.

Who is the study for?
This trial is for adults with advanced solid tumors, including bladder and bile duct cancer, who've had no luck with standard treatments or can't tolerate them. Phase I includes various tumor types; Phase II focuses on those with specific FGFR gene changes in urothelial carcinoma or cholangiocarcinoma.Check my eligibility
What is being tested?
ICP-192 is being tested to see if it's safe and effective for treating advanced solid tumors with FGFR gene alterations. The study has two parts: the first part tests different doses (Phase I) and the second expands the dose to more patients (Phase II).See study design
What are the potential side effects?
While not specified here, drugs like ICP-192 may cause side effects such as fatigue, nausea, liver issues, or reactions at the injection site. Side effects depend on individual patient factors and drug dosage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.
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My tests show a change in my FGFR gene.
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My cancer has returned or worsened after first-line chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
MTD
OBD
+2 more
Secondary outcome measures
AUC
DCR
DOR
+3 more
Other outcome measures
Drug exposure
PD biomarker

Trial Design

1Treatment groups
Experimental Treatment
Group I: ICP-192Experimental Treatment1 Intervention
Dose Escalation Phase ICP-192 Dose Expansion Phase ICP-192

Find a Location

Who is running the clinical trial?

Beijing InnoCare Pharma Tech Co., Ltd.Lead Sponsor
41 Previous Clinical Trials
4,418 Total Patients Enrolled

Media Library

ICP-192 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04565275 — Phase 1 & 2
Bladder Cancer Research Study Groups: ICP-192
Bladder Cancer Clinical Trial 2023: ICP-192 Highlights & Side Effects. Trial Name: NCT04565275 — Phase 1 & 2
ICP-192 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04565275 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are actively engaging in this experiment?

"Five different medical centres are participating in this trial, including Mid Florida Hematology and Oncology located in Orange City, The Ohio State University based out of Columbus, and Arizona Oncology situated in Tucson."

Answered by AI

How many individuals have registered for participation in the research?

"Correct. The official listing on clinicaltrials.gov states that this medical experiment, which was first uploaded on February 1st 2021, is currently seeking participants. Approximately 45 recruits need to be sourced from 5 different facilities."

Answered by AI

Are there still opportunities for individuals to participate in this experiment?

"Correct. The clinicaltrials.gov database confirms that this research trial, which was initially published on February 1st 2021, is actively recruiting patients for participation. A total of 45 participants need to be sourced from 5 different medical sites."

Answered by AI

What are the prime goals that this trial is attempting to achieve?

"The primary outcome of this long-term trial, which is estimated to run for up to three years, will be the incidence of treatment-related adverse effects. Additionally, phase I: dose escalation peak concentration (Cmax), phase II: dose expansion overall survival (OS) and progression free survival (PFS) will also be evaluated."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Research Alliance
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Apr 2025